MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. UMBILICAL CORD CLAMP, 100/CS, UMBILICAL CORD CLAMP, 100/CS; DEVICE, OCCLUSION, UMBILICAL

Model Number	5833
Medical Device Problem Codes	Difficult to Open or Close (2921); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A deroyal umbilical cord clamp was placed on an infant.The nurse heard a noise that sounded like the baby passing gas, but upon investigation realized that the cord clamp had popped open.When reported her coworkers had voiced that this had happened previously, especially with healthy thick cords, that the clamp will not stay closed - which is concerning as an infant could bleed out form an open cord.
Additional Manufacturer Narrative
A user facility reported on (b)(6) 2023, that "a deroyal umbilical cord clamp was placed on an infant.The nurse heard a noise that sounded like the baby passing gas, but upon investigation realized that the cord clamp had popped open.When reported her coworkers had voiced that this had happened previously, especially with healthy thick cords, that the clamp will not stay closed - which is concerning as an infant could bleed out form an open cord." this event was also reported in a medwatch #mw5118129.Deroyal industries requested the sample, but it was not able to be returned.Deroyal reviewed work orders, labels, and failure modes and effects analysis (fmea) and found no issues.Device history records were reviewed for lots 56775868, 56171010, and 57040337.For each lot, the quality control specialist was required to pull 128 parts from each case of product produced and snap the umbilical cord clamp closed.All results were passing.Every 3 hours, operators were required to visually inspect 8 parts against the manufacturing specification.All visual results were acceptable.At the beginning of the mold run and end of the mold run, a pressure test is required.Pressure testing yielded acceptable results.In addition, the quality control specialist performed a tightened inspection that consists of checking each case, once complete, for short shots.Each case was inspected with no short shots found.A shipping and handling error was ruled out as this would likely result in additional products within the pack exhibiting a deformity.A storage error was also ruled out as this would likely not have impacted the product in this manner unless damage occurred.Root cause: because the sample was not returned, the true root cause could not be identified.Potential root causes that could not be eliminated are a manufacturing error (potentially a non-fully filled part) or clinician error in applying the umbilical cord clamp.Corrective and preventive action: due to the inability to determine the true root cause, a corrective action could not be identified.Deroyal will continue to monitor for trends surrounding this item and issue.(b)(4).This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: UMBILICAL CORD CLAMP, 100/CS, UMBILICAL CORD CLAMP, 100/CS
• Common Device Name: DEVICE, OCCLUSION, UMBILICAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19950049
• Report Number: 1060680-2023-00006
• Device Sequence Number: 8923770
• Product Code: FOD
• UDI-Device Identifier: 00749756173797
• UDI-Public: 00749756173797
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5833
• Device Lot Number: 57577716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown